MEDLINE SYRSI101292Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 10888277657298), received between May 28, 2019 and Sep 28, 2026 — classified as 1 injury, 31 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (15 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Difficult or Delayed Activation; Material Integrity Problem

  It was reported that they are "hard to activate the safety sheath- they feel locked and require a bit more force than staff are used to."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50912874 ↗
• MalfunctionSep 28, 2026Obstruction of Flow

  It was reported that "Defective/ poor quality. Gets stuck so, cannot expel the product, like an air lock or the safety is unable to unlock."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50910634 ↗
• MalfunctionSep 24, 2026Dull, Blunt

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50885689 ↗
• MalfunctionSep 24, 2026Use of Device Problem

  It was reported that "there may be an issue with the needle safety device with our insulin syringes" after "the nurse thought she had engaged the safety, but it had disengaged itself, leading to the needle stick." "The needle would not stay covered."

  Patient problems: Needle Stick/Puncture

  MAUDE report 50884757 ↗
• MalfunctionSep 23, 2026Protective Measures Problem

  It was reported that "The safety part is not staying locked. Keeps sliding it down, making it NOT safety".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50870622 ↗
• MalfunctionSep 21, 2026Material Protrusion/Extrusion

  It was reported that NEEDLE STICK IS GOING THROUGH THE CAP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50840115 ↗
• MalfunctionSep 17, 2026Mechanical Problem

  It was reported that our nurses that they have been noticing the insulin syringes safety latches are not latching.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50807233 ↗
• OtherSep 17, 2026Material Integrity Problem

  It was reported that "can¿t fill them up with anything without the needle retracting and being un-usable" and "we can¿t use without needle getting exposed/retracted."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50804770 ↗
• MalfunctionSep 12, 2026Protective Measures Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50746626 ↗
• MalfunctionSep 9, 2026Material Integrity Problem

  It was reported that "these needles that¿s coming to Jacksonville are defected. The safety is faulty you could stick yourself.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50694635 ↗
• MalfunctionApr 15, 2026Appropriate Device Problem Term/Code Not Available

  SYRINGES GET "AIR LOCKS".

  Patient problems: Insufficient Information

  MAUDE report 24887367 ↗
• MalfunctionJul 26, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  ACCOUNT REPORTED ISSUES ACTIVATING THE SAFETY MECHANISM. NO SAMPLE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19835191 ↗
• MalfunctionJul 26, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE INITIAL REPORTER INDICATED THAT WHEN THE NEEDLE CAP WAS REMOVED, THE NEEDLE DETACHED FROM THE SYRINGE. NO SERIOUS INJURY OR ADVERSE IMPACT TO A PATIENT OR A USER WAS ORIGINALLY REPORTED. TO DATE, NO INFORMATION HAS BEEN RECEIVED TO INDICATE THAT A USER OR A PATIENT EXPERIENCED A DEATH, SERIOUS INJURY, MEDICAL INTERVENTION, FOLLOW-UP CARE, OR OTHER ADVERSE HEALTH IMPACT ASSOCIATED WITH THE REPORTED PROBLEMS/ISSUES. NO SAMPLES AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19835146 ↗
• MalfunctionJul 26, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE REPORTING FACILITY INDICATED THAT NEEDLES ARE "GOING THROUGH THE CAP." TO DATE, NO INFORMATION HAS BEEN RECEIVED TO INDICATE THAT THERE WAS A SYRINGE-RELATED DEFECT RELATED TO THE ORIGINAL REPORT OR THAT THE REPORT INVOLVED AN OUT OF SPECIFICATION SYRINGE. TO DATE, NO INFORMATION HAS BEEN RECEIVED TO INDICATE THAT A USER OR A PATIENT EXPERIENCED A DEATH, SERIOUS INJURY, MEDICAL INTERVENTION, FOLLOW-UP CARE, OR OTHER ADVERSE HEALTH IMPACT ASSOCIATED WITH THE REPORTED PROBLEM/ISSUE.NO SAMPLE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19834883 ↗
• MalfunctionJul 26, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE INITIAL REPORTER INDICATED THAT A NEEDLE BROKE OFF OF THE SYRINGE WHILE MEDICATION WAS BEING ADMINISTERED BY A NURSE. ACCORDING TO THE UNIT MANAGER, THE DEVICE IS NEW TO THE STAFF AND THE NURSE "HAD DIFFICULTY USING THE PRODUCT TO DRAW THE INSULIN AND FEELS THE NEEDLE MAY HAVE BENT IN THE PROCESS." AFTER THE NEEDLE BROKE OFF, IT WAS REPORTEDLY REMOVED FROM THE PATIENT'S ARM. A SYRINGE-SPECIFIC DEFECT WAS NOT INDICATED AT THE TIME OF THE ORIGINALLY REPORT AND NO SERIOUS INJURY OR ADVERSE IMPACT TO A PATIENT OR A USER WAS REPORTED. NO SAMPLE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19834867 ↗
• MalfunctionJul 26, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT WHEN A USER REMOVES THEIR HAND FROM THE SYRINGE PLUNGER WHILE DRAWING MEDICATION FROM A VIAL, THE SYRINGE "AUTOMATICALLY" DRAWS UP FLUID INTO THE SYRINGE. THE REPORTING FACILITY ALSO INDICATED THAT LEAKAGE OF INSULIN WAS NOTED WHENEVER FILLED SYRINGES WERE TRANSPORTED USING THE FACILITY'S PRESSURIZED TUBE VACUUM SYSTEM. TO DATE, NO INFORMATION HAS BEEN RECEIVED TO INDICATE THAT A USER OR A PATIENT EXPERIENCED A DEATH, SERIOUS INJURY, MEDICAL INTERVENTION, FOLLOW-UP CARE, OR OTHER ADVERSE HEALTH IMPACT ASSOCIATED WITH THE REPORTED PROBLEM/ISSUE.NO SAMPLE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19834865 ↗
• MalfunctionJul 26, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  ACCORDING TO THE FACILITY ON 08/27/22, AFTER ADMINISTERING INSULIN TO A PATIENT THE SYRINGE DID NOT STAY CLOSED AND THE SYRINGE POKED THE STAFF MEMBER'S FINGER'. PER THE FACILITY THERE WAS NO SERIOUS INJURY OR MEDICAL INTERVENTION NOTED WITH THE FINGER STICK. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE SAMPLE IS AVAILABLE AND HAS BEEN REQUESTED TO BE RETURNED FOR EVALUATION. THERE WAS NO SERIOUS INJURY IDENTIFIED, FOLLOW UP CARE NEEDED OR MEDICAL INTERVENTION REPORTED RELATED TO THE INCIDENT. THIS IS NOT A REPORTABLE EVENT. NO SAMPLE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19834848 ↗
• MalfunctionJul 26, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE REPORTING FACILITY INDICATED THAT THE NEEDLE WAS FOUND TO HAVE A "DOUBLE NEEDLE HEAD." TO DATE, NO INFORMATION HAS BEEN RECEIVED TO INDICATE THAT THERE WAS A SYRINGE-RELATED DEFECT RELATED TO THE ORIGINAL REPORT OR THAT THE REPORT INVOLVED AN OUT OF SPECIFICATION SYRINGE. TO DATE, NO INFORMATION HAS BEEN RECEIVED TO INDICATE THAT A USER OR A PATIENT EXPERIENCED A DEATH, SERIOUS INJURY, MEDICAL INTERVENTION, FOLLOW-UP CARE, OR OTHER ADVERSE HEALTH IMPACT ASSOCIATED WITH THE REPORTED PROBLEM/ISSUE. NO SAMPLE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19834847 ↗
• MalfunctionJul 26, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED BY THE FACILITY THAT AFTER THE NURSE ADMINISTERED INSULIN TO A PATIENT THE NURSE EXPERIENCED A NEEDLE STICK. PER THE FACILITY REPORT, AFTER INJECTING THE INSULIN WITH HER RIGHT HAND THE NURSE ATTEMPTED TO USE HER RIGHT INDEX FINGER TO PUSH THE SAFETY SLIDE UP TO ACTIVATE THE FEATURE AND SHE PUNCTURED HER RIGHT INDEX FINGER WITH THE USED SYRINGE. THE NURSE WASHED THE AREA WITH SOAP AND WATER AND WENT TO THE LOCAL URGENT CARE TO HAVE A HEPATITIS PANEL AND HIV TEST PERFORMED PER FACILITY PROTOCOL. PER THE FACILITY REPORT THE NURSE IS FEELING FINE AND THERE IS NO EVIDENCE OF INFECTION. THE ACTUAL NEEDLE USED WAS DISPOSED OF AND WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19834846 ↗
• MalfunctionJul 26, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  3 NEEDLE STICKS IN THE PAST MONTH.NOT SURE IF THEY ARE DIFFERENT INDIVIDUALS.IT WAS REPORTED BY THE FACILITY THAT AFTER THE NURSE ADMINISTERED INSULIN TO A PATIENT THE NURSE EXPERIENCED A NEEDLE STICK. PER THE FACILITY REPORT, AFTER INJECTING THE INSULIN WITH HER RIGHT HAND THE NURSE ATTEMPTED TO USE HER RIGHT INDEX FINGER TO PUSH THE SAFETY SLIDE UP TO ACTIVATE THE FEATURE AND SHE PUNCTURED HER RIGHT INDEX FINGER WITH THE USED SYRINGE. THE NURSE WASHED THE AREA WITH SOAP AND WATER AND WENT TO THE LOCAL HOSPITAL TO HAVE A HEPATITIS PANEL AND HIV TEST PERFORMED PER FACILITY PROTOCOL. PER THE FACILITY REPORT THE NURSE IS FEELING FINE AND THERE IS NO EVIDENCE OF INFECTION. THE ACTUAL NEEDLE USED WAS DISPOSED OF AND WAS NOT RETURNED TO THE MANUFACTURER FOR VALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19834808 ↗
• MalfunctionJul 26, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE REPORTING FACILITY INDICATED THAT THE NEEDLE COMPONENT IS BENDING AND THAT THE SAFETY MECHANISM OF THE NEEDLE FALLS OFF. TO DATE, NO INFORMATION HAS BEEN RECEIVED TO INDICATE THAT THERE WAS A SYRINGE-RELATED DEFECT RELATED TO THE ORIGINAL REPORT OR THAT THE REPORT INVOLVED AN OUT OF SPECIFICATION SYRINGE. TO DATE, NO INFORMATION HAS BEEN RECEIVED TO INDICATE THAT A USER OR A PATIENT EXPERIENCED A DEATH, SERIOUS INJURY, MEDICAL INTERVENTION, FOLLOW-UP CARE, OR OTHER ADVERSE HEALTH IMPACT ASSOCIATED WITH THE REPORTED PROBLEM/ISSUE.NO SAMPLES AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19834805 ↗
• MalfunctionJul 26, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE INITIAL REPORTER INDICATED THAT DURING AN INJECTION, A NEEDLE DETACHED FROM THE SYRINGE. NO SERIOUS INJURY OR ADVERSE IMPACT TO A USER OR A PATIENT WAS ORIGINALLY REPORTED. TO DATE, NO INFORMATION HAS BEEN RECEIVED TO INDICATE THAT A USER OR A PATIENT EXPERIENCED A DEATH, SERIOUS INJURY, MEDICAL INTERVENTION, FOLLOW-UP CARE, OR OTHER ADVERSE HEALTH IMPACT ASSOCIATED WITH THE REPORTED PROBLEMS/ISSUES.NO SAMPLE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19834804 ↗
• MalfunctionJul 26, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  ACCORDING TO THE FACILITY ON (B)(6)2022 A REGISTERED NURSE WAS WIPING THE ARM OF THE PATIENT'S RIGHT UPPER ARM WHEN THEY DISCOVERED A RETAINED NEEDLE IN THE PATIENT'S SKIN. PER THE FACILITY NO SERIOUS INJURY WAS NOTED OTHER THAN A SMALL PUNCTURE FROM THE NEEDLE IN THE PATIENTS RIGHT ARM. ACCORDING TO THE FACILITY LABS WERE DRAWN ON THE PATIENT POST NEEDLE STICK AND NO ADDITIONAL MEDICAL CARE/INTERVENTION WAS REQUIRED. PER THE FACILITY THE PATIENT WAS DISCHARGED.NO SAMPLE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19834770 ↗
• MalfunctionJul 26, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE INITIAL REPORTER INDICATED THAT "NEEDLES ARE BREAKING OFF FROM SYRINGES." NO SERIOUS INJURY OR ADVERSE IMPACT TO A PATIENT OR A USER WAS ORIGINALLY REPORTED. TO DATE, NO INFORMATION HAS BEEN RECEIVED TO INDICATE THAT A USER OR A PATIENT EXPERIENCED A DEATH, SERIOUS INJURY, MEDICAL INTERVENTION, FOLLOW-UP CARE, OR OTHER ADVERSE HEALTH IMPACT ASSOCIATED WITH THE REPORTED PROBLEMS/ISSUES. NO SAMPLES AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19834764 ↗
• MalfunctionJul 26, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE INITIAL REPORTER INDICATED, THAT THE END OF THE SYRINGE WAS BENT, PRIOR TO USE. TO DATE, NO INFORMATION HAS BEEN RECEIVED TO INDICATE, THAT A USER OR A PATIENT EXPERIENCED A DEATH, SERIOUS INJURY, MEDICAL INTERVENTION, FOLLOW-UP CARE, OR OTHER ADVERSE HEALTH IMPACT ASSOCIATED WITH THE REPORTED PROBLEMS/ISSUES. NO SAMPLE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19834763 ↗